Oxcarbazepine as an Adjunct of Antipsychotic Therapy in Acute Schizophrenia

NCT00637234 | Completed Phase 2 DMC

• 1 other identifier: OXC-SCZ CTRI476BDE06
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

Over recent years an approach with the adjunctive administration of various anticonvulsant drugs has been discussed and a limited number of open and controlled studies were performed for carbamazepine, valproic acid, and lamotrigine. While the latter shows promising effects in the long run it has some handling difficulties in the acute treatment of acute psychotic exacerbations. Valproic acid has shown inconsistent effects in schizophrenia with no significant effects in a recent controlled study. Although still controversially discussed, carbamazepine was found to offer beneficial effects in the treatment of schizophrenia. Nonetheless, data on these effects are limited by small sample sizes or poor design of most of the respective studies. Furthermore, the complex pharmacological interactions of new atypical neuroleptics with carbamazepine underline the necessity of alternative strategies in adjuvant treatment of schizophrenia as well as in combined treatment of bipolar disorders with mood stabilizers and neuroleptics. Oxcarbazepine (OXC) is a new anticonvulsant drug that acts as a pro-drug for the 10-monohydroxy metabolite (MHD), an active metabolite also of carbamazepine that is suggested to be responsible for most of its therapeutic actions. Therefore, the pharmacological action of OXC is very well comparable to carbamazepine whilst there are fewer unwanted side effects of OXC regarding eg. skin rush, and effects on blood compounds or cardiotropic effects. The effects of OXC on cytochrome CYP3A4 and CYP3A5 are moderate and UDPGT is only slightly affected by OXC, which leads to less interaction with other compounds on a pharmacokinetical level. In psychiatry, the few studies published until now report positive effects of OXC in bipolar disorders. With regards to our own clinical observations, OXC has shown potential beneficial effects as an adjunct in the treatment of schizophrenia as well that require further evaluation in a controlled study design.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Amount of Olanzapine Co-medication

  5 weeks

Secondary Outcomes (6)

• BPRS

  6 weeks

• Extrapyramidal symptoms

  6 weeks

• Weight gain

  6 weeks

• Prolactin levels in plasma

  6 weeks

• ECG QT-C time elongation

  6 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: Oxcarbazepine

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oxcarbazepine DRUG

Oxcarbazepine (OXC), 300 mg tablets, up to 600 mg three times daily

Also known as: Trileptal FCT 300MG.002, Film-coated tablet, Batch No.: X208 0802, Code: 3750031.002, Date of manufacture: September 2002, Date of evaluation: May 2004

1

Placebo DRUG

Placebo, 300 mg tablets, up to 600 mg three times daily

Also known as: TRL PLA FCT.005, Film-coated tablet, Batch No.: X207 0802, Code: 3750411.005, Date of manufacture: September 2002, Date of evaluation: May 2004

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of schizophrenia or schizophreniform psychosis according to DSM-IV
• BPRS score \> 36 and BPRS psychosis cluster \> 12
• Ability to provide written informed consent
• Participants are required an adequate contraception

You may not qualify if:

• Any severe neurological or somatic disorder
• Other psychiatric disorders including addictive disorders
• Positive urine drug screening for any compound except benzodiazepines
• No pregnancy or breast feeding

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (2)

Isar-Amper-Klinikum gemeinnützige GmbH, Klinik Taufkirchen (Vils)

Taufkirchen (Vils), Bavaria, 84416, Germany

Location

University of Cologne, Dept. of Psychiatry and Psychotherapy

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Schizophrenia

Interventions

Oxcarbazepine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbamazepine; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• F. Markus Leweke, MD

  University of Cologne

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 17, 2008
• Study Start: July 1, 2004
• Primary Completion: April 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 24, 2008

Record last verified: 2008-07

Locations

DE (2)